TORQ

GUDID 00795847979281

Imperial Bag & Paper Co. LLC

Nitrile examination/treatment glove, non-powdered, non-antimicrobial

• Primary Device ID: 00795847979281
• NIH Device Record Key: 28cd54fa-3edc-4458-8d19-2aafa6f687e7
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: TORQ
• Version Model Number: GLOVES-XL
• Company DUNS: 137977224
• Company Name: Imperial Bag & Paper Co. LLC
• Device Count: 10
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: false
• Lot Batch: false
• Serial Number: false
• Manufacturing Date: false
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: false
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	00795847979281 [Unit of Use]
GS1	10795847979288 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K123869

FDA Product Code

• LZA: Polymer Patient Examination Glove

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: false

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2024-09-02
• Device Publish Date: 2024-08-25

On-Brand Devices [TORQ]

• 00795847979335: HDGLOVES-XXL
• 00795847979328: HDGLOVES-XL
• 00795847979311: HDGLOVES-M
• 00795847979304: HDGLOVES-L
• 00795847979298: GLOVES-XXL
• 00795847979281: GLOVES-XL
• 00795847979274: GLOVES-S
• 00795847979267: GLOVES-M
• 00795847979250: GLOVES-L